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A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

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ClinicalTrials.gov Identifier: NCT01936181
Recruitment Status : Completed
First Posted : September 5, 2013
Results First Posted : August 29, 2016
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Remicade (infliximab)
Drug: SB2 (proposed biosimilar to infliximab)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
SB2 (Proposed Biosimilar to Inflixmab)

SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70

SB2 (proposed biosimilar to infliximab)

Remicade (Infliximab)

Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46

At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70.

Remicade (Infliximab), Switch to SB2

SB2 3mg/kg at week 54, 62, 70

SB2 (proposed biosimilar to infliximab)

Remicade (Infliximab), Continue as Remicade

Remicade 3mg/kg at week 54, 62, 70

Remicade (infliximab)


Participant Flow for 2 periods

Period 1:   Randomised, Double-blind
    SB2 (Proposed Biosimilar to Inflixmab)   Remicade (Infliximab)   Remicade (Infliximab), Switch to SB2   Remicade (Infliximab), Continue as Remicade
STARTED   291   293   0   0 
COMPLETED   227   225   0   0 
NOT COMPLETED   64   68   0   0 
Adverse Event                27                21                0                0 
Protocol Violation                1                5                0                0 
Lack of Efficacy                5                6                0                0 
Lost to Follow-up                0                1                0                0 
Pregnancy                0                1                0                0 
Physician Decision                4                4                0                0 
Withdrawal by Subject                23                26                0                0 
Subjects from Eastern Ukraine sites                4                4                0                0 

Period 2:   Transition-extension
    SB2 (Proposed Biosimilar to Inflixmab)   Remicade (Infliximab)   Remicade (Infliximab), Switch to SB2   Remicade (Infliximab), Continue as Remicade
STARTED   201   0   94   101 
COMPLETED   186   0   88   96 
NOT COMPLETED   15   0   6   5 
Adverse Event                3                0                3                1 
Lost to Follow-up                3                0                1                2 
Physician Decision                2                0                0                1 
Withdrawal by Subject                7                0                2                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
SB2 (Proposed Biosimilar to Inflixmab)

SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70

SB2 (proposed biosimilar to infliximab)

Remicade (Infliximab)

Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46

At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70.

Total Total of all reporting groups

Baseline Measures
   SB2 (Proposed Biosimilar to Inflixmab)   Remicade (Infliximab)   Total 
Overall Participants Analyzed 
[Units: Participants]
 291   293   584 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.6  (11.92)   52.6  (11.74)   52.1  (11.83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      232  79.7%      236  80.5%      468  80.1% 
Male      59  20.3%      57  19.5%      116  19.9% 


  Outcome Measures

1.  Primary:   American College of Rheumatology 20% Response Criteria (ACR20)   [ Time Frame: Week 30 ]

2.  Secondary:   ACR20   [ Time Frame: Week 54, Week 78 ]

3.  Secondary:   American College of Rheumatology 50% Response Criteria (ACR50)   [ Time Frame: Week 30, Week 54, Week 78 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Disease Activity Score Based on a 28 Joint Count (DAS28)   [ Time Frame: Week 30, Week 54, Week 78 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director, Clinical Development
Organization: Samsung Bioepis
phone: +82 31 8061 4534


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT01936181     History of Changes
Other Study ID Numbers: SB2-G31-RA
First Submitted: September 2, 2013
First Posted: September 5, 2013
Results First Submitted: July 13, 2016
Results First Posted: August 29, 2016
Last Update Posted: September 14, 2017